Hyland's Baby Teething Tablets [Calcarea Phosporica 6X HPUS — Class I drug recall D-0863-2017
Terminated recall by Standard Homeopathic Company, reported 2017-05-31, distributed nationwide. Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from the cal
| Recall number | D-0863-2017 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Standard Homeopathic Company, Los Angeles, CA, United States |
| Recall initiated | 2017-04-13 |
| Classified | 2017-05-24 |
| Reported by FDA | 2017-05-31 |
| Terminated | 2017-10-26 |
| Distributed | Nationwide (US) |
| Quantity | 10,263,585 bottles |
| Reason classes | labeling, potency |
| UPC / GTIN / UDI-DI | 00354973312715, 00354973312722, 00354973312739, 00354973313712, 00354973314818, 00354973315211 |
| NDC | 54973-3127-01, 54973-3127-02, 54973-3127-03 |
Product
Hyland's Baby Teething Tablets [Calcarea Phosporica 6X HPUS, Chamomilla 6X HPUS, Coffea Cruda 6X HPUS, Belladonna 12X HPUS (0.0000000000003% alkaloids, calculated)] Quick-Dissolving Tablets, packaged in a) 40-count bottles (NDC 54973-3127-3) (UPC 3 54973 31273 9); b) 135-count bottles (NDC 54973-3127-1) (UPCs 3 54973 31271 5, 3 54973 31371 2, 3 54973 31481 8); and 250-count bottles (NDC 54973-3127-2) (UPCs 3 54973 31272 2, 3 54973 31521 1), Manufactured for: Hyland's, Inc., Los Angeles, CA 90061.
Reason for recall
Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the product labels.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0863-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.